Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of VIZIMPRO Under Japanese Medical Practice)

N/ACompletedNCT04155541

Pfizer40 enrolled

Overview

Secondary data collection study: safety and efficacy of VIZIMPRO under Japanese medical practice

Study Type

OBSERVATIONAL

Enrollment

Conditions

EGFR Mutation-positive Inoperable or Reccrent NSCLC

Interventions

dacomitinib hydrateDRUG

The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose should be reduced appropriately according to the patient's condition.

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patient with EGFR mutation-positive inoprable or recurrent NSCLC who have not received VIZIMPRO(dacomitinib hydrate) Exclusion Criteria: * Exclusion criteria is not provided in this study

Locations (1)

Pfizer Japan

Tokyo, Japan

Outcomes

Primary Outcomes

The number and proportion of patients with ILD (interstitial lung disease)

The number and proportion of patients with ILD (interstitial lung disease) will be tabulated by subgroup by risk factor

Time frame: 52 weeks form the start date

Secondary Outcomes

Response rate

Response rate will be calculated. The response rate is defined as the propotion of patients with a best ovarall response of CR ro PR in the effectiveness analysis set.

Time frame: 52 weeks from the start date

The number and population of patients with adverse reactions

The number and population of patients with adverse reactions will be tabulated.

Time frame: 52 weeks from the start date

Data from ClinicalTrials.gov

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